A multicenter interventional study on the efficacy and safety of continuous absorbable barbed sutures in rectus abdominis muscle fascia closure technique during free abdominal flap harvesting.

Not Applicable

Recruiting

• Conditions: Patients undergoing reconstructive surgery with free abdominal flap transfer; free abdominal flap transfer

• Registration Number: JPRN-jRCT1052230095
• Lead Sponsor: omura Tadashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients aged 20 years or older at the time of informed consent
2. Patients who plan to undergo reconstruction using a free abdominal flap (regardless of reconstruction site) within the target period
3. Patients who received an explanation of this study from the attending doctor before surgery and obtained written consent to participate
4. Patients expected to survive for 180 days or more after surgery

Exclusion Criteria

Patients who meet any one of the following criteria are excluded from the study.
1. Patients with incisional hernia before surgery
2. Patients who have undergone abdominal flap surgery in the past
3. Patients who have difficulty standing on their own or with assistance, making it impossible to determine hernia or bulge
4. Patients taking oral steroids
5.Patients with sensitization or metal allergy to triclosan
6.Patients judged to be inappropriate by the doctor in charge of this clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence or absence of hernia or bulge up to 180 days after surgery

Secondary Outcome Measures

Name	Time	Method
Presence or absence of bulges up to 90 days after surgery<br>Presence or absence of bulges up to 180 days after surgery<br>Presence or absence of hernia up to 90 days after surgery<br>Presence or absence of hernia up to 180 days after surgery<br>Time required for fascial closure<br>Hernia/bulge-free period<br>Presence or absence of complication